Apotex is a Canadianpharmaceutical corporation. Founded in 1974 by Dr. Bernard Sherman, the company is the largest producer of generic drugs in Canada, with sales exceeding $2 billion (CAD) a year.[3] The company produces more than 300 generic pharmaceuticals in approximately 4,000 dosages, and has 500 molecules under development. Apotex exports products to over 115 countries around the globe.[3] There are more prescriptions filled with Apotex products in Canada than that of any other pharmaceutical company, close to 90 million per year.

Apotex manufactures and distributes generic medications for a range of diseases and health conditions that include cancer, diabetes, high cholesterol, glaucoma, infections and blood pressure.

Apotex is a member of The Canadian Generic Pharmaceutical Association (CGPA),[4] the Generic Pharmaceutical Association (GPhA),[5] an associate member of the Canadian Animal Health Institute (CAHI),[6] the Canadian Association for Pharmacy Distribution Management (CAPDM),[7] as well as the Greater Toronto Area's Partners in Project Green.[8]

Apotex began with limited staff in a 5,000-square-foot warehouse. When Dr. Bernard Sherman started Apotex, at first he was losing so much money "that his wife urged him to close his business before he lost everything." In 1980, Apotex was first to market a generic version of propranolol, the blood-pressure drug, which boosted Apotex's company profile.

Warehouse where Apotex first began in 1974.

By the mid-90s, Apotex was earning $700 million in annual sales, which allowed it to control approximately 40 per cent of the Canadian generic drug market. [9] As an important development step, in 2003 Apotex became the first to market a generic version of Paxil, the antidepressant originally patented by GlaxoSmithKline. Apotex launched their generic version of Paxil "at risk", meaning before patent litigation between Apotex and GlaxoSmithKline over Paxil had concluded. [10]

In 2007, Apotex acquired Belgium generic drug maker, Topgen ESV, from Zambon Group SpA of Italy as a way for Apotex to expand its European footprint.[11] That same year, Apotex acquired Lareq Pharma SL of Spain from Industria Quimica Y Farmaceutica to extend the company's presence in Western Europe. [12] In 2010, Apotex launched a generic version of Pfizer Inc.'s cholesterol-lowering Lipitor drug in Canada after four years of patent litigation with Pfizer. Apotex's generic version was launched under the name, Apo-Atorvastatin. [13] This saved provincial health programs over $800 million per year.

In 2010, Apotex was listed in the eighth position in a report published by FiercePharma listing the top U.S. generic companies based on sales from January 2009 to December 2009. [14]

In 2012, Apotex launched a generic version of Crestor, the cardiovascular drug originally patented and manufactured by AstraZeneca. Apotex's generic version of Crestor is called Apo-Rosuvastatin. [15]

In 2006, Sanofi-Aventis SA and Bristol-Myers Squibb Co., the producers and patent owners of Plavix, the blood thinner drug, settled a patent lawsuit with Apotex. [16][17] In the settlement, Apotex agreed not to sell a generic version of Plavix until September 2011, in exchange for an unspecified amount of money. [16] The settlement contained a clause that allowed Apotex to bring to market a generic version of Plavix in the situation where the agreement between Apotex and Bristol-Myers was not upheld by the U.S. Federal Trade Commission. In this situation, Apotex would be able to bring to market a generic version of Plavix, even before the expiration of Sanofi-Aventis SA and Bristol-Myers Squibb's patent on the drug. [16][17]

On July 28, 2006, the Attorney General rejected the agreement between Apotex and Sanofi-Aventis SA and Bristol-Myers Squibb Co. On August 8, 2006, Apotex launched their generic version of Plavix and during the five days that the company was able to produce the drug, Apotex "flooded the market with many months' supply of the generic drug."[16][17]

In 2013, Apotex began selling a biosimilar version of Amgen's Neulasta in Europe, a blockbuster drug used by cancer patients in chemotherapy as a way to boost white blood count. Apotex's version is known as Grastofil (filgrastim) and is licensed for sale in Europe by Stada Arzneimittel. [18] In February 2015, the FDA accepted Apotex's application of its filing of Grastofil in the United States. [19]

In 1991, Apotex opened Apotex Fermentation in Winnipeg to develop fermentation-based technologies for the production of Active Pharmaceutical Ingredients (APIs) and to manufacture APIs for eventual sale as final dosage forms in Canada and internationally. The factory employs 150 people.

In January 2004, ApoPharma was founded. It is the subsidiary responsible for research and development of new chemical entities.[3]

Over the years, Apotex has provided medicines for international humanitarian support efforts. Since 2012, Apotex has worked in conjunction with The Teasdale-Corti Foundation to provide medicine for St. Mary's Hospital Lacor (also known as Lacor Hospital) in Uganda. Apotex continued to provide medicines for Lacor Hospital in 2013, and in total, has donated approximately $1.2 million in medicines to Lacor Hospital.

Technicians working in an Apotex lab.

In September 2014, in response to the spread of the chikungunya virus in Haiti, Apotex worked with the humanitarian organization Direct Relief to donate more than $2.2 million in medical aid to the country.[21]

In 2009, Apotex began providing medicines to the Mully Children’s Family Foundation, an organization located outside of Nairobi, Kenya that is dedicated to rescuing and supporting orphaned and homeless children.[22] Thus far, Apotex has provided three shipments of medications to the Foundation.

In 2004, a legislation was enacted under Canada's Pledge to Africa Act called Canada's Access to Medicines Regime (CAMR), which pledged to improve access to drugs to developing countries that lack the resources to manufacture the medications or purchase them at cost. Canada's Access to Medicines Regime allowed for patents on medications to be overridden through a "compulsory licensing" so that generic drug manufacturers could supply these drugs to developing countries at lower prices. [23]

Beginning in 2005, Apotex worked on developing an HIV treatment involving three drugs, AZT, 3TC and Navirapin, which could be sent to countries in need under CAMR. [24] In September 2008, after four years of fighting "a morass of red tape and petty politics", Apotex shipped seven million doses of Apo-TriAvir, a generic AIDS medication, to Rwanda. The shipment provided enough medication to treat 21,000 Rwandans for a full year. [23]

As of 2008, Apotex had given more than $21 million to pharmacy schools across Canada,[25] and in 2008, Apotex donated $1.5 million to The University of Saskatchewan's College of Pharmacy, which was the largest donation given to the College of Pharmacy.[25]

On August 22, 2013, Apotex announced that it would donate $10 million toward the construction of the new Humber River Hospital (HRH) in Toronto, Canada. Apotex's donation would go towards the building of Humber River Hospital's Emergency Department.[26]

Apotex founded the Apotex Foundation, a privately held charitable organization, which has donated over $50 million in medicines over the last 10 years. Critical medicines have been shipped to every disaster zone around the globe to provide assistance to humans in need. Apotex was also the only Canadian company to develop and manufacture a combination drug for AIDS patients in Rwanda.

Apotex is known for actively fighting patent protections on brand-name drugs, primarily through litigation means. A New York Times cover piece on Apotex's founder, Bernard Sherman, described Sherman's work to get new generic drugs to market as "something of a crusade." The article goes on to explain that while some generic drug manufacturers cut deals with brand-name manufacturers over drug patents, Bernard Sherman and Apotex are against such deal-making. [10]

In a 2008 article on pharmaceutical patent cases, The Globe and Mail cited Apotex as being "prepared to wage expensive courtroom battles with the help of high-priced talent from such firms as Goodmans LLP". [27] In a 2007 National Post article, Apotex revealed that it spent roughly $60-million a year on legal fees, both in defense of the company and working toward expanding the number of generics on the market. [28]

Apotex received a warning letter from the U.S. Food and Drug Administration (FDA) regarding the Etobicoke plant on June 25, 2009 for good manufacturing practice (GMP) violations.[29] It also received a warning letter citing similar GMP violations in the Signet plant on March 29, 2010.[30] FDA issued an import ban on all drugs manufactured at these two plants and prevented the company from seeking new marketing authorizations in the U.S on August 28, 2009.[30] The import ban was subsequently lifted on May 6, 2011.[31] On February 29, 2012, Apotex filed a claim to the International Centre for Settlement of Investment Disputes seeking arbitration with the U.S.A. In the filing, Apotex cited unfair treatment by FDA which constituted a violation of the North American Free Trade Agreement (NAFTA). Apotex further claimed that the action of FDA ‘decimated its business’.[32] On August 26, 2014, NAFTA tribunal rejected Apotex’s claim.[33]

FDA inspected the same plants again in 2013 and issued warning letters for more problems.[34] In April 2014, FDA banned a manufacturing plant owned by Apotex in Bangalore, India. In the warning letter, FDA indicated that the plant routinely deleted failed test results and replaced with retest results that passed. FDA found that the violations are systemic and were dated back for many years, having the same issues noted in past inspections since 2006.[34]

On 17 May 2013, a group of pregnant Canadian women filed a class-action lawsuit against Apotex, after it was discovered that the company's recalled birth control pill packages contained more placebos than usual.[35]

In October 2014, the Federal Court of Canada released decisions on Section 8 of the Patented Medicines (Notice of Compliance) Regulations as it relates to litigation between Sanofi-Aventis and Apotex (Sanofi-Aventis et al. v. Apotex Inc.). Section 8 explains how a brand-name drug manufacturer may be liable to a generic drug manufacturer for damages caused by a generic drug's delay in reaching market, caused as a result of unsuccessful prohibition proceedings on the part of the brand-name manufacturer. [36] Sanofi argued that the current framework for quantifying damages in a hypothetical market inherently leads to a windfall for the generic manufacturer. [37] In October 2014, the Federal Court of Canada affirmed that section 8 of the Regulations was constitutionally and jurisdictionally valid, a decision which Sanofi appealed.[38]

In April 2015, the Supreme Court of Canada (SCC) affirmed the Federal Court's section 8 quantification decision with with respect to the litigation between Sanofi and Apotex. This was the first time that the Supreme Court of Canada had the opportunity to consider section 8 of the Patented Medicines Regulations.[38]